Director, Quality Control

US-IL-Chicago
1 month ago
ID
2017-1986
Adello Biologics, LLC

Overview

Adello Biologics is a privately held, U.S.-based biotechnology company that leads with science to accelerate development and drive manufacturing efficiency. The company's aim is to provide high-quality, affordable biosimilars to patients worldwide. Headquartered in Piscataway, NJ and driven by a team of highly skilled industry veterans, Adello is advancing a strategic pipeline of proteins and complex monoclonal antibodies with lead candidates in oncology and immunology. For more information, visit www.Adellobio.com

 

Our vision is to make biosimilar medications affordable. We are seeking candidates interested in contributing to a bourgeoning field that has the potential to help millions of patients. As a growing company, Adello Biologics offers real development opportunities for candidates excited to take on responsibility, make an immediate impact and help us achieve our vision. As part of a close knit team, you’ll have the opportunity to work in a unique, high science industry while expanding your career. We are seeking a Director, Quality Control to be based out of our Chicago, IL location.  

Responsibilities

SUMMARY:

Adello Biologics is seeking a highly motivated leader to join our growing team as the Director of our Quality Control laboratories. The successful candidate will be responsible for all functions of the Quality Control team, including sample management, scheduling testing in support of both late-stage clinical and commercial biosimilar products in cGMP-compliant laboratories, and management of the stability program. The QC leader will also be expected to engage in continuous improvement initiatives to drive efficiency and effectiveness of our Quality Systems. A strong background in protein chemistry will be applied to the ability to perform and troubleshoot techniques such as HPLC, SDS-PAGE, cell-based bioassays, capillary electrophoresis, ELISA, and standard compendial assays. A demonstrated ability to successfully mentor staff and collaborate across multiple departments to drive timely resolution of projects, investigations, and process improvements is required.

 

Essential Duties and Responsibilities:

  • Serves as the Subject Matter Expert for interactions with regulatory inspectors and external testing laboratories
  • Sample Management
  • Stability Program
  • Scheduling
  • Strong knowledge of cGMP, Quality Systems, and ICH / regulatory guidance.
  • Oversee investigations regarding OOS and deviations to analytical procedures.
  • A commitment to Adello’s Vision, Mission, and Values is essential.

Qualifications

PREREQUISITES:

 

Education:

  • Bachelor’s or Master’s degree in biotechnology, biochemistry, chemistry, or related field with 15+ years of experience in a pharmaceutical/biotech QC laboratory with at least 10 years in a management role.
  • Demonstrated expertise in cGMP, ICH, USP/EP, and other global compendial regulations and guidance

 

 Experience:  

  • Previous management experience in a cGMP laboratory with responsibility for oversight of OOS/lab investigations and method validation.
  • Strong background in protein chemistry and experience troubleshooting analytical results.
  • Demonstrated success at writing, revising, and complying with SOPs, policies, and QC methods.

 

SPECIALIZED KNOWLEDGE AND SKILLS:

  • Previous experience supporting regulatory inspections (e.g. PAI).
  • Familiarity with preparing regulatory dossiers and data packages for interactions with regulatory agencies.
  • Continuous improvement mindset.

 

  

WORKING ENVIRONMENT/PHYSICAL REQUIREMENTS:

 

General Working Environment:

  • Some time spent in an office doing office work (reading, writing, reviewing, and editing documents).
  • Significant amount of time spent in the laboratory and corresponding manufacturing areas.
  • On occasion, must be able to work extended hours or weekend hours.

 

Noise:

  • No extraordinary noise levels.

 

Standing/Lifting:

  • Must be able to lift at least 25 lbs.

 

Visual:

  • No extraordinary requirements.

 

Stress:

  • High-paced environment structured to meet ambitious project goals.

 

Travel:

  • Minimal travel may be required, but not to exceed 10%.

  

 

Adello Biologics, LLC provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics. In addition to federal law requirements, Adello Biologics, LLC complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, and transfer, leaves of absence, compensation and training.

 

Notice To Agency And Search Firm Representatives

Adello Biologics is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Adello employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Adello. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

 

Options

Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
Share on your newsfeed